AB0884 Disease outcomes in patients with psoriatic arthritis completing 12 months of apremilast treatment - Real-world data from the REWARD study
Authors: R. Bos, T. Jansen, I. Bridges, S. De Jong, M. Vis
Journal: Annals of the Rheumatic Diseases (2022)

Background Patients with moderately active psoriatic arthritis (PsA) and limited joint involvement have considerable disease burden 1,2 . Recent data shows these patients have a high likelihood of achieving treatment goals if treated with apremilast 3 . This is the first report of outcomes in patients with PsA who received apremilast for 12 months in Dutch clinical practice. Objectives We report disease outcomes, including the PsA Impact of Disease (PsAID) 12-item questionnaire, swollen joint count (SJC), tender joint count (TJC), dactylitis and enthesitis, among patients in the prospective, multicenter, observational REWARD study who completed 12 months of apremilast treatment. Methods The ongoing REWARD study enrolled patients who had initiated apremilast for the treatment of PsA in the Netherlands between 13 April 2017 and 24 March 2021, and includes up to 12 months follow-up 1,4 . We report interim data from patients with data available as of 16 September 2021. Baseline data are summarized separately for patients who discontinued apremilast before their month 12 study visit (stoppers) and patients still receiving apremilast at their month 12 visit (completers). Post baseline data are summarized for completers. Continuous data are summarized using mean and SD, categorical data are summarized using n and percent. Results 98 patients were included in this interim analysis; 32 had completed 12 months of apremilast treatment (completers), 54 had discontinued apremilast before month 12 (stoppers), 12 were ongoing in the study. Compared with stoppers, completers were more likely to be biologic naïve and have dactylitis, and had lower BSA. All other baseline characteristics were similar (Table 1). Among completers, all PsAID domains improved after 3 months of apremilast treatment and these improvements were maintained through month 12 (Figure 1). Mean SJC and TJC decreased between baseline and month 12 (SJC, 4.2 and 1.0 at baseline and month 12, respectively; TJC, 7.1 and 3.3, respectively). The proportion of completers with SJC, TJC, enthesitis and dactylitis scores of 0 increased from baseline to month 12 (Figure 1B). The proportion of completers reporting at least one adverse event (AE) was comparable to the overall study population (14/32 [44%] and 48/98 [49%], respectively); the reported adverse events were similar to the known safety profile of apremilast. Table 1. Baseline characteristics All=all patients included in this interim analysis; Completers= patients that received apremilast for 12 months; Stoppers= patients that stopped apremilast treatment prior to 12 months. BMI=Body Mass Index, PsO=Psoriasis, BSA PsO= Body Surface Area Psoriasis, SJC=Swollen Joint Count, TJC=Tender Joint Count, PsAID=Psoriatic Arthritis Impact of Disease, VAS=Visual Analog Scale, CRP= C-reactive protein, cDAPSA=Clinical Disease Activity in Psoriatic Arthritis, Rem=Remission, Mod=Moderate, PsA= Psoriatic Arthritis Figure 1. (A) PSAID scores in completers and (B) percentage of completers with no swollen joints, no tender joints, no dactylitis and no enthesitis at baseline (BSL), month 3, 6 and 12 (M3, M6, M12). Conclusion In this interim analysis of the REWARD study, patients completing 12 months of apremilast treatment were more likely to be biologic naïve than patients who discontinued apremilast within 12 months of initiation, and had significant decreases in TJC, SJC, dactylitis and enthesis during apremilast treatment. Completed patients also reported decreased PsAID scores during apremilast treatment, indicating improvements in their quality of life. References [1]Jansen TL, et al. Ann Rheum Dis. 2019; 78:913 [abstract FRI0442] [2]Wervers et al. J Rheumatol. 2018;45:1526. [3]Mease PJ, et al. Arthritis Care Res. 2020; 72, 6, 814–821 [4]Bos R, et al. Ann Rheum Dis. 2021; 80:805 [POS1053] Acknowledgements Sylvia de Jong and Claire Desborough, Amgen employees, provided medical writing and editorial assistance. Disclosure of Interests Reinhard Bos Consultant of: AbbVie BV, Genzyme Europe, Grant/research support from: Galapagos, Tim Jansen Speakers bureau: Grunenthal, Sobi, Consultant of: AbbVie, Celgene Corporation, Grant/research support from: ReumaNederland, Olatec, Grunenthal, Ian Bridges Shareholder of: Amgen, Employee of: Amgen, Sylvia de Jong Shareholder of: Amgen, Employee of: Amgen, Novartis, Marijn Vis Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Grant/research support from: Novartis, Pfizer